Drug Resistant Diseases Fueled by Counterfeit Medications Impact Developed Nations

As has been repeatedly discussed on this blog, drug resistant strains of diseases have evolved in underdeveloped countries by counterfeit medications that contain just enough of the active ingredient of the drug used to treat the disease to fool rudimentary analytical testing used to verify the drugs authenticity. Unfortunately these fake medications, with minor amounts of the real drug add injury to insult by not only not treating the disease but in creating drug resistant strains of the disease itself.

Until lately this issue has largely impact underdeveloped nations in Africa and Asia but as you can see by recent media reports and this article which appears in the Minneapolis Star Tribune, this phenomenon is now hitting US shores with drug resistant strains of Tuberculosis.

This problem of drug resistant strains in Africa kills thousands every day.
Developed and underdeveloped nations need to take action and utilize a variety of solutions to put an end to this issue which makes deadly diseases more sophisticated and deadlier.

Solutions such as XStream System’s, XT250 are able to do on-site, molecular screening of pharmaceuticals that can verify active ingredients, excipients and packaging to authenticate and verify medications inside their sealed, unit-of-sale container would drastically curtail the ability of counterfeiters to sell and distribute substandard medications in developed and underdeveloped nations.

To read the Star Tribune story visit: http://www.startribune.com/lifestyle/health/80160622.html?elr=KArks7PYDiaK7DUvDE7aL_V_BD77:DiiUiacyKUnciaec8O7EyUr.

To learn more about XStream Systems and its XT250, visit: http://www.xstreamsystems.net/.

Up to 30 per cent of EU generics 'contain falsified APIs'

On Friday, SecuringPharma, published an interesting article on the quality of active pharmaceutical ingredients (APIs) in European generics.

The European Fine Chemicals Group claims that 20 to 30 percent of the APIs come from unapproved sources.

EFCG board member Guy Villax quoted that figure, which he attributed to EU inspectors, at a press conference at the Conference on Pharmaceutical Ingredients (CPhI) held last week in Madrid, Spain.

This causes a huge challenge to the validity and efficiency of the finished product as a single batch of an API can reach from 10,000 to 1,000,000 patients. Currently a manufacturer receives Good Manufacturing Practice (GMP) certification based not only on their own practices, but those of their suppliers as well. If their suppliers are in reality not as they have stated, you can see how this circumvents the inspection process.

Council of Europe is drafting legislation on counterfeit medicines to be reviewed by 40 countries. However, EFCG does not agree with the current wording of the EU's draft directive which suggests that API manufacturers can be inspected by their own domestic authorities, providing their enforcement systems are deemed 'equivalent' by the EU, i.e. they conform to ICH Q7 and are based on regular inspections.

This would work with countries such as the USA, Japan and Australia, said Villax, but he is concerned that equivalence could be granted for political reasons to other countries where the systems may be prone to fraud and corruption.

We at XStream Systems agree that the quality of the finished product is only as good as the quality of the ingredients that are contained therein. In the United States this was only too evident in last year’s case of tainted heparin, where the active ingredient had been tainted by unapproved suppliers and resulted in the death of over 80 people.

To view the entire article visit: www.securingpharma.com.

Where, Oh Where Did My Medicine Come From?

You may think you know where your medicine originated. It came from Pfizer, or Merck, or Bayer, or some other big name pharmaceutical manufacturer. The question is where did they get it?

Many of our modern day medications are complex. They might be synthesized from chemicals or use biological agents and all have some kind of filler, bulking agent, or suspension liquid. So where do all those ingredients come from and why can’t you tell where your medication was made?

Almost 80% of the active ingredients come from overseas and many of the companies that supply the fillers or chemicals are not inspected by the FDA because the product is not considered pharmaceutical. Even to inspect only the active ingredients, the FDA has stated it would take them over 13 years to inspect each plant.

What’s more – pharmaceutical companies are only required to list active ingredients not the raw material or fillers that make up the medicine.

It’s like a giant puzzle; but what if you could zoom out and see the whole picture, match it against the picture on the box and know if something didn’t fit? That might be just around the corner with EDXRD technology. A new product, the XT250 System, uses this technology to build an industry standard of a compound and then use it when comparing a sample. The software will even do the thinking for you to determine if it is or is not a match – no scientific knowledge required. It’s like a pharmaceutical lie detector to stand guard at our gates.

It would give consumers the peace of mind to know “what they see is what they get” because after all, isn’t that what really counts?